Effects of Maplirpacept (PF-07901801),Tafasitamab, and Lenalidomide in People With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Part of paid clinical trials in Baton Rouge, Louisiana.

Sponsor
Pfizer
Study ID
NCT05626322
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Maplirpacept — DRUG
    Intravenous infusion
  • Tafasitamab — DRUG
    Intravenous infusion
  • Lenalidomide — DRUG
    Oral (by mouth)

Study Details

The purpose of this study is to learn about the effects of three study medicines \[maplirpacept (PF-07901801), tafasitamab, and lenalidomide\] when given together for the treatment of diffuse large B-cell lymphoma (DLBCL) that: * is relapsed (has returned after last treatment) or * is refractory (has not responded to last treatment) DLBCL is a type of non-Hodgkin lymphoma (NHL). NHL is a cancer of the lymphatic system. It develops when the body makes abnormal lymphocytes. These lymphocytes are a type of white blood cell that normally help to fight infections. This study is seeking participants who are unable or unwilling to undergo an autologous stem cell transplantation (when doctors put healthy blood cells back into your body) or CAR-T immune cell therapy. Everyone in this study will receive three medicines: maplirpacept (PF-07901801), tafasitamab and lenalidomide. Participants will receive maplirpacept (PF-07901801) and tafasitamab at the study clinic by intravenous (IV) infusion (given directly into a vein) and lenalidomide will be taken by mouth at home. Study interventions will be administered in 28-day cycles. Maplirpacept (PF-07901801) will be given weekly for the first three cycles and then every two weeks. Tafasitamab will administered on Days 1, 4, 8, 15 and 22 in cycle 1, weekly in cycles 2 and 3 and then every 2 weeks in cycle 4 and beyond. Lenalidomide will be taken every day for Days 1 to 21 of each 28-day cycle for the first 12 cycles. Participants can continue to take maplirpacept (PF-07901801) and tafasitamab until their lymphoma is no longer responding. Lenalidomide is discontinued after 12 cycles. Maplirpacept (PF-07901801) will be given at different doses to different participants. Everyone taking part will receive approved doses of tafasitamab and lenalidomide. We will compare the experiences of people receiving different doses of PF-07901801. This will help us to determine what dose is safe and effective when combined with the other 2 study medicines.

Key Dates

Start date
Aug 4, 2023
Status verified
Sep 2025
Primary completion
Aug 12, 2024
Completion
May 1, 2025

Study Design

Enrollment
6 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1b
    Participants will be allocated to sequential dose levels of maplirpacept (PF-07901801), administered in combination with standard doses of tafasitamab and lenalidomide, to select two doses for further evaluation in Phase 2. Approximately 20 participants will be enrolled.
  • Experimental: Phase 2
    Participants will be randomized to 1 of 2 different dose levels of maplirpacept (PF-07901801) which will be administered in combination with standard doses of tafasitamab and lenalidomide. Approximately 50 participants will be enrolled (25 per dose).

Primary Outcome Measure

Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (28 Days) ]

Locations (4)

FacilityCityStateZIPSite coordinators
Mary Bird Perkins Cancer CenterBaton RougeLouisiana70809-
University of MichiganAnn ArborMichigan48109-
Lifespan Cancer InstituteProvidenceRhode Island02903-
The Miriam HospitalProvidenceRhode Island02906-

Find similar trials in Baton Rouge, LA

By research site
Mary Bird Perkins Cancer Center· Baton Rouge, LAUniversity of Michigan· Ann Arbor, MILifespan Cancer Institute· Providence, RIThe Miriam Hospital· Providence, RI

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